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KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.
The need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamina bolus plus Dexamethasone bolus plus infusion ketamine | Experimental | Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA) |
|
| Ketamine bolus plus ketamine infusion | Experimental | Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA. |
|
| Dexametasone arm | Active Comparator | Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA |
|
| Saline bolus | Placebo Comparator | Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated | Consumption of morphics | 4 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative nausea and vomiting (PONV). | Incidence of postoperative nausea and vomiting | 4 hours post operative |
| Efficay of study treatment regarding pain at 3 postoperative months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emili Leon, MD | Hospital Dr Josep Trueta and Hospital Santa Caterina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Dr Josep Trueta | Girona | 17007 | Spain |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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Single-center, controlled, prospective and randomized clinical trial, phase IV, to determine the effect of perioperative intravenous administration of ketamine and dexamethasone in patients undergoing lumbar arthrodesis
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To preserve the masking of the study, the randomization system has been carried out by the pharmacy service personnel using the EPIDAT 4.0 program and only the personnel responsible for the pharmacy will know the randomization tables and codes. The main investigator will have the emergency codes in case of need by contacting the pharmacy service
| Dexamethasone | Drug | A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery. Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration |
|
| Physiologic saline | Drug | placebo |
|
Pain at 3 postoperative months assessed by EVA scale pain. This is a visual analogue scale regarding pain.It consists of a 10-centimeter horizontal line, at the ends of which are the extreme expressions of a symptom. In the left is the absence or less intensity and in the right the greater intensity. The patient is asked to mark on the line the point that indicates the intensity and measure it with a millimeter ruler. The intensity is expressed in centimeters or millimeters. The evaluation will be: 1.Mild pain if the patient scores pain less than 3. 2.Moderate pain if the evaluation is between 4 and 7. 3.Severe pain if the evaluation is equal to or greater than 8.
| 3 months |
| Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%) | Rate of patients that presented adverse events | 4 hours post operative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |